It’s time to close the gap between adult and pediatric medical devices
I have spent decades as a health-care executive and pediatric surgeon. I am often asked to reflect on the biggest advancements that have been developed to save children’s lives.
While I can acknowledge that there are many technologies available to surgeons today that did not exist when I first began operating, I can’t ignore the fact that innovation in medical devices and technology for children continues to occur much more slowly than it does for adults.
The examples are many, but here’s one: The pacemaker. Many of us have a friend or loved one who has this lifesaving device. First introduced in the 1960s, insertion is a routine procedure in adults, causing little disruption to the patient’s life.
However, there is no pacemaker in the market that is designed for pediatric use. When a child needs a pacemaker, doctors have no choice but to use a device made for an adult. Placing these adult-sized pacemakers in a tiny body requires open-chest surgery. The devices are so large in relation to the child’s body, that it can interfere with the child’s ability to sit upright and sometimes creates a visible bulge beneath the rib cages.
The procedure is life-saving, but not a solution optimally made for a growing child’s health and wellbeing.
We see this every day in our nation’s pediatric hospitals. Surgeons are manipulating adult devices to create solutions for children’s bodies because it’s the only available option.
To give you an idea of how wide the innovation gap is, on average over the past decade only 24 percent of life-saving medical devices approved by the Food and Drug Administration (FDA) — those that go through two specific regulatory pathways — have an indication for pediatric use. And the majority of those are designated for children twelve years and older.
The reasons for this are varied. Children’s devices represent a much smaller market, which can be an economic deterrent for device makers. Designing devices for children is more difficult because they grow and are very active. When device makers are ready to launch a clinical trial, the number of sites is very limited since not all pediatric hospitals are equipped to accommodate a trial.
Simply put, we must do better for children.
Children’s National Hospital has been an active proponent of initiatives to increase the pace of pediatric innovation. We recognize the need for even more collaborations with public and private entities and policymakers to achieve this.
As more voices join us, some progress is being made. We applaud Congress for enacting legislation and initiatives that support pediatric innovation, such as the Pediatric Device Consortia Grants Program. In collaboration with University of Maryland A. J. Clark School of Engineering, Children’s National leads one of the five FDA-funded consortia, dubbed the National Capital Consortium for Pediatric Device Innovation. This consortium provides seed funding and technical advice to sponsors of pediatric medical devices that are selected on a competitive basis. Through these initiatives and more, we’ve seen firsthand how accelerating the pace of pediatric research and the commercialization of pediatric devices results in better outcomes for kids.
And just this summer, the House voted to add $1 million to the budget of the FDA to support pediatric device development. The House and Senate are negotiating final budget for next year now, and we are hopeful that funding will be included.
That said, we all play different roles in this effort. Inside Children’s National, we face the daily challenges created by the gap between pediatric and adult health-care innovation, but we’re also going beyond our own walls to fast track solutions by building the nation’s first research and innovation campus dedicated to pediatrics.
Set to open in 2020 and located on a nearly 12 -acre portion of the former Walter Reed Army Medical Center in Washington, D.C., the vision of the Children’s National Research & Innovation Campus is to be an ecosystem where clinicians, researchers, innovators, regulators, investors and manufacturers come together to accelerate the translation of discoveries into new treatments and technologies benefitting children everywhere.
Public and private partnerships are vital components of this ecosystem. We just announced a prestigious academic partner for this campus, Virginia Tech. They will collaborate with us to establish a biomedical research facility that combines our clinical expertise with their leadership in technology to develop novel therapeutics and treatments.
This partnership allows us to jointly recruit researchers and facilitates greater collaborations between our two institutions. This builds upon a decade of work with Virginia Tech which has already resulted in shared research grants, collaborative publications and shared intellectual property.
Earlier this year, we announced JLABS @Washington, DC will occupy a 32,000-square-foot space on the campus. The Johnson & Johnson Innovation incubator will be open to biotech, medical device, consumer and health technology startups, offering mentorship and lab space, and also seed funding to those that are selected through the QuickFire challenges.
We anticipate a lot of exciting developments from this innovation campus. We’ll need government decision makers to remain involved and to support legislation that not only encourages device manufacturers and startups to innovate for kids, but also streamlines the process of bringing these devices to market faster.
We’re fortunate to have relationships with federal partners like the FDA, the National Institutes of Health and the Biomedical Advanced Research and Development Authority. Shared learning between developers and regulators through the Children’s National Research & Innovation Campus will be beneficial to everyone and can yield better, dedicated regulatory and clinical trial processes for pediatric devices, while also helping innovators to navigate the specific nuances.
As we learn, we’ll share with you and ask for your support in putting that knowledge to good use. Help us close the gap between adult and pediatric medical device innovation to bring beneficial new technologies and treatments to children faster than ever before.
Kurt Newman, M.D., is the president and chief executive officer of Children’s National Hospital.
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